SonALAsense
SonALAsense is a clinical-stage biotech developing sonodynamic therapy, a non-invasive drug-device combination of SONALA-001 (intravenous ALA) and MR-guided focused ultrasound to selectively destroy tumor cells. It serves pediatric DIPG and adult recurrent glioblastoma patients, with expansion into blood cancers.
- Company typePrivate
- Founded2016
- HeadquartersBerkeley, United States
- Headcount1–10
- GTM typeB2B
- OfferingHardware or Manufacturing
What SonALAsense does
SonALAsense is a clinical-stage biotechnology company developing sonodynamic therapy (SDT), a non-invasive drug-device combination treatment for cancer. The core technology pairs SONALA-001, an intravenous formulation of aminolevulinic acid (ALA), with INSIGHTEC's Exablate 4000 Type 2 MR-guided focused ultrasound device. The drug accumulates selectively in tumor cells via their elevated heme synthesis demand and is converted to protoporphyrin IX; focused ultrasound activation at the tumor site then triggers localized reactive oxygen species production, causing selective tumor cell death while sparing healthy brain tissue. The company has pioneered the clinical translation of SDT, being the first to advance the modality into clinical trials, with a focus initially on diffuse intrinsic pontine glioma (DIPG) in pediatric patients and recurrent glioblastoma multiforme (rGBM) in adults, and an expanded program in blood cancers funded by ARPA-H.
The company's clinical programs include a Phase 1/2 SDT-201 trial in DIPG that has treated 15 subjects to date, a Phase 2 SDT-202 trial in rGBM with approximately 50 participants planned, and a first-in-human Phase 0/1 trial in recurrent high-grade glioma that produced positive proof-of-concept data on targeted tumor cell death and tolerability. SONALA-001 has received FDA Orphan Drug Designation for malignant gliomas (2021) and FDA Fast Track Designation for DIPG (2023). Trials are conducted across 9 major US academic cancer centers, including NYU, MD Anderson, Mayo Clinic, Cleveland Clinic, UCSF, Children's National Hospital, Phoenix Children's Hospital, West Virginia University, and the Ivy Brain Tumor Center.
The business is pre-revenue, with operations funded by a cumulative >$70M raised through a ~$2M NCI SBIR grant (2020), a ~$25M Series B financing (June 2022), and a $46M ARPA-H award (December 2024). Revenue, when generated, will depend on a hospital-based delivery model at centers equipped with MR-guided focused ultrasound capability, targeting initially the ~300 annual US DIPG diagnoses and a larger rGBM population. The go-to-market is enterprise-style clinical adoption via neuro-oncology departments at leading academic hospitals, supported by patient advocacy partnerships (Cancer Commons, My DIPG Navigator, DIPG/DMG Collaborative) and scientific engagement through conferences such as the Society for Neuro-Oncology annual meeting.
SonALAsense firmographics
Firmographics- Name
- SonALAsense
- Legal name
- SonALAsense, Inc.
- Website
- https://sonalasense.com
- Company type
- Private
- Founded year
- 2016
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- SonALAsense is a clinical-stage biotech developing sonodynamic therapy, a non-invasive drug-device combination of SONALA-001 (intravenous ALA) and MR-guided focused ultrasound to selectively destroy tumor cells. It serves pediatric DIPG and adult recurrent glioblastoma patients, with expansion into blood cancers.
- Ownership category
- akta.pro rank
SonALAsense industry classification
Industry- Product category
- Clinical-Stage Oncology Therapeutics (Drug-Device Combination)
- NAICS
- Research and Development in Biotechnology (except Nanobiotechnology) (541714)
- SIC
- Biological Products, (No Disgnostic Substances) (2836)
- akta.pro primary industry
- Rare Pediatric & Congenital Disorder Therapies (HLAIAIAN)
Keywords
Where SonALAsense is headquartered
LocationHeadquarters
- HQ city
- Berkeley
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
SonALAsense business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Operations, Marketing or Sales
Revenue model
- Pre-Commercial / Grant Funding: Currently pre-revenue. Company is funded through a $46MM ARPA-H award for blood cancers, private financing (over $20M), and NCI SBIR grants. No commercial product revenue has been generated as the therapy is in Phase 1/2 clinical trials.
Go-to-market motion1 record
Distribution channels1 record
Marketing channels7 records
SonALAsense product offering
Product offeringCore offering
SonALAsense develops sonodynamic therapy (SDT), a non-invasive drug-device combination treatment for cancer. Its lead asset, SONALA-001 (intravenous aminolevulinic acid/ALA), is administered systemically and accumulates in tumor cells, where it is converted to protoporphyrin IX; focused ultrasound delivered via Insightec's Exablate 4000 Type 2 MR-guided system then activates PpIX to produce reactive oxygen species that selectively destroy cancer cells. The platform is being evaluated in clinical trials for diffuse intrinsic pontine glioma (DIPG), recurrent glioblastoma (rGBM), recurrent high-grade gliomas (rHGG), and blood cancers.
Product overview
SonALAsense is a clinical-stage company developing sonodynamic therapy (SDT) as a first-in-class, noninvasive drug-device combination for cancer treatment. The core offering consists of SONALA-001 (a proprietary intravenous formulation of aminolevulinic acid) combined with MR-guided focused ultrasound (Exablate 4000 Type 2.0 from Insightec). SDT is a platform technology designed to treat multiple tumor types by selectively targeting cancer cells through metabolic disruption of heme synthesis. The company is the first to advance SDT into clinical trials, with active programs in recurrent glioblastoma (rGBM) and diffuse intrinsic pontine glioma (DIPG), and plans to expand into blood cancers. Currently conducting multiple clinical trials: Phase 0/1 in recurrent high-grade gliomas, Phase 1/2 SDT-201 in DIPG (completed), and Phase 2 SDT-202 in recurrent glioblastoma.
Differentiator
Problem solved
Functional benefit
Products and services
- SONALA-001 Proprietary intravenous aminolevulinic acid (ALA) formulation that accumulates selectively in cancer cells as the first committed building block in heme synthesis and is converted to protoporphyrin IX (PpIX); upon focused ultrasound activation, PpIX generates reactive oxygen species that destroy tumor cells. It is the investigational drug component of SonALAsense's sonodynamic therapy platform intended for treating DIPG, recurrent glioblastoma, and other cancers.
- Sonodynamic Therapy (SDT) Platform A non-invasive drug-device combination therapy pairing SONALA-001 (drug) with Insightec's Exablate 4000 Type 2 MR-guided focused ultrasound (device) to selectively target and kill tumor cells. SDT metabolically exploits cancer cells' elevated heme synthesis demand, causing immediate and programmed cell death only in tumor cells while leaving normal cells intact. It is a platform technology applicable across multiple oncology indications including brain tumors and blood cancers.
- SDT-201 (Phase 1/2 DIPG Trial) Phase 1/2 dose-escalation clinical trial examining safety, pharmacokinetics, and preliminary efficacy of ascending SONALA-001 drug and focused ultrasound energy dose combinations with the Exablate 4000 Type 2.0 MR-guided focused ultrasound in pediatric and young adult subjects with diffuse intrinsic pontine glioma (DIPG). Trial has identified the Recommended Phase 2 Dose and has treated 15 DIPG subjects with no dose-limiting toxicities observed.
- Phase 0/1 Recurrent High-Grade Glioma (rHGG) Trial First-in-human Phase 0/1 clinical trial conducted by Dr. Nader Sanai at the Ivy Brain Tumor Center evaluating sonodynamic therapy in recurrent high-grade gliomas (rHGG). The study established proof of concept that SDT rapidly induces targeted oxidative stress and cell death in human glioma tissue while being well tolerated in all patients.
- SDT-202 (Phase 2 Recurrent Glioblastoma Trial) Phase 2 open-label, dose-escalation trial of sonodynamic therapy in recurrent glioblastoma (rGBM) building on the prior proof-of-concept Phase 0/1 trial. The study is evaluating safety, optimal dose, and efficacy, with planned enrollment of approximately 50 participants across multiple US sites including UCSF, Mayo Clinic, Ivy Brain Tumor Center, MD Anderson, NYU, and West Virginia University.
Quantifiable outcome
- 15 DIPG patients treated with no dose-limiting toxicities observed
- +2 more outcomes
Companies that use SonALAsense
Customer profileNamed customers1 record
Segments3 records
Ideal customer profiles2 records
SonALAsense technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature3 records
SonALAsense partnerships and signals
Strategic signalPartnerships
13 partnerships are on record, tiered core and major.
- InsighteccorePartnership to use Insightec's Exablate 4000 Type 2 MR-guided focused ultrasound device in combination with SONALA-001 for tumor treatment. Insightec provides the hardware platform that enables the non-invasive, focused ultrasound procedure to activate the pro-drug in tumor tissue.
- Ivy Brain Tumor Center at Barrow Neurological InstitutecoreClinical trial partner for Phase 1/2 studies of SONALA-001 + focused ultrasound in brain tumor patients. Located in Phoenix, Arizona, Ivy Brain Tumor Center is one of the nation's leading brain tumor research and treatment facilities.
- Children's National HospitalcoreClinical trial partner conducting pediatric DIPG studies. Children's National in Washington D.C. is a leading pediatric hospital with specialized neuro-oncology program critical for DIPG patient recruitment.
- Phoenix Children's HospitalcoreClinical trial partner for pediatric DIPG and brain tumor studies. Phoenix Children's Hospital provides access to pediatric neuro-oncology patients in the Southwest US.
- UCSF Medical CentercoreClinical trial site for adult glioblastoma and brain tumor studies. UCSF is a leading academic medical center with renowned neuro-oncology program.
- Cleveland CliniccoreClinical trial site for brain tumor studies. Cleveland Clinic is a top-ranked academic medical center with extensive neuro-oncology research capabilities.
- Mayo CliniccoreClinical trial site for brain tumor studies. Mayo Clinic provides access to neuro-oncology expertise and patient population across its Rochester, Minnesota and Arizona campuses.
- MD Anderson Cancer CentercoreClinical trial site for brain tumor studies. MD Anderson in Houston is the nation's leading cancer hospital with extensive experience in novel therapy clinical trials.
- NYU Langone HealthcoreClinical trial site for brain tumor studies. NYU Langone's Perlmutter Cancer Center has leading neuro-oncology program and focused ultrasound capabilities.
- West Virginia University Cancer InstitutemajorClinical trial site for brain tumor studies in Appalachian region. WVU provides geographic diversity in trial site location and access to patient population not served by major coastal cancer centers.
- Cancer CommonsmajorPatient support organization helping connect cancer patients with cutting-edge treatments and clinical trials. Cancer Commons assists DIPG and glioblastoma patients in understanding their options and finding appropriate clinical trials.
- My DIPG NavigatormajorPatient advocacy organization dedicated to DIPG awareness and support. Provides resources and navigation assistance for families affected by DIPG, helping connect patients with clinical trial opportunities.
- DIPG DMG National Tumor BoardmajorMulti-institutional tumor board bringing together DIPG/DMG experts to review cases and advance treatment approaches. Participation enables knowledge sharing and clinical trial awareness among specialist physicians.
Scale indicators5 records
Recent moves7 records
Expansion highlights6 records
SonALAsense competitors and assessment
Company assessmentDirect peers
- Novocure: Commercial-stage oncology company developing Tumor Treating Fields (TTFields) for glioblastoma and other solid tumors. Most directly comparable to SonALAsense as a device-based, non-invasive therapy targeting the same rGBM patient population, with FDA approval and Medicare coverage already established.
- CNS Pharmaceuticals: Clinical-stage biopharmaceutical company developing berubicin, a doxorubicin analog that crosses the blood-brain barrier, for recurrent glioblastoma. Directly comparable as a small clinical-stage biotech competing in the same rGBM indication with similar size and development stage.
- Orbus Therapeutics: Clinical-stage company developing eflornithine (DFMO) for recurrent glioblastoma. Comparable as a small clinical-stage biotech focused exclusively on GBM treatment with a single late-stage asset competing for the same patient population.
- Kazia Therapeutics: Clinical-stage oncology company developing paxalisib for glioblastoma and brain metastases. Directly comparable as a small-cap, clinical-stage biotech focused on CNS oncology drug development targeting similar patient populations to SonALAsense's rGBM program.
- Diffusion Pharmaceuticals: Clinical-stage biopharmaceutical company developing trans sodium crocetinate (TSC) for glioblastoma and other solid tumors. Comparable as a small clinical-stage biotech focused on improving cancer treatment outcomes in brain tumors with novel mechanism approaches.
- Candel Therapeutics: Clinical-stage biotech developing oncolytic viral immunotherapies for high-grade gliomas and other solid tumors. Directly comparable as a CNS oncology developer with active programs in recurrent glioblastoma that compete for the same clinical investigators and patient population.
Emerging players
- Day One Biopharmaceuticals: Commercial-stage biotech focused on developing targeted therapies for rare pediatric cancers, including DIPG-related programs. Comparable to SonALAsense for its pediatric rare-disease oncology focus and ability to secure FDA approvals in underserved pediatric indications.
- Lumos Pharma: Clinical-stage rare disease biotech focused on pediatric endocrine and metabolic disorders with similar funding scale and clinical-stage profile. Comparable as a small-cap rare disease biotech navigating similar regulatory pathways and capital markets dynamics, though addressing different therapeutic areas.
- Insightec: Maker of the Exablate 4000 MR-guided focused ultrasound system that SonALAsense's therapy depends on. Both a critical technology partner and an emerging oncology player; Insightec is investigating its focused ultrasound platform in oncology and other indications beyond its established essential tremor business.
Others
- DUSA Pharmaceuticals: Historical leader in ALA-based photodynamic therapy (Levulan) where SonALAsense Founder/CSO Stuart Marcus was a founding executive. Comparable as a precedent for how an ALA-based oncology platform can achieve commercial scale, and as a benchmark for the underlying drug technology that SonALAsense has adapted into sonodynamic therapy.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat4 records
Key risks5 records
Key highlights6 records
Customer concentration
SonALAsense social profiles
Digital presenceSonALAsense compliance and trust
Trust signalCompliance2 records
SonALAsense financial estimates
Financial estimateRevenue estimate
Valuation estimate
SonALAsense leadership team
Management profileNumber of profiles
Profiles5 records
SonALAsense funding detail
Funding detailFunding overview
Funding rounds4 records
Investors3 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
SonALAsense M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about SonALAsense
What does SonALAsense do?
SonALAsense develops sonodynamic therapy (SDT), a non-invasive drug-device combination treatment for cancer. Its lead asset, SONALA-001 (intravenous aminolevulinic acid/ALA), is administered systemically and accumulates in tumor cells, where it is converted to protoporphyrin IX; focused ultrasound delivered via Insightec's Exablate 4000 Type 2 MR-guided system then activates PpIX to produce reactive oxygen species that selectively destroy cancer cells. The platform is being evaluated in clinical trials for diffuse intrinsic pontine glioma (DIPG), recurrent glioblastoma (rGBM), recurrent high-grade gliomas (rHGG), and blood cancers.
Is SonALAsense a public or private company?
SonALAsense is a private company. It is classified as venture growth investor backed and is currently operating.
When was SonALAsense founded?
SonALAsense was founded in 2016. It employs 1 to 10 people.
Where is SonALAsense based?
SonALAsense is headquartered in Berkeley, United States, in the North America region.
How does SonALAsense make money?
One revenue line is on record: pre-Commercial / Grant Funding.
Who are SonALAsense's main competitors?
Direct peers on record are Novocure, CNS Pharmaceuticals, Orbus Therapeutics, Kazia Therapeutics, Diffusion Pharmaceuticals and Candel Therapeutics. Emerging players are Day One Biopharmaceuticals, Lumos Pharma and Insightec. DUSA Pharmaceuticals is listed as an others.
Does SonALAsense have an API?
No public API is recorded for SonALAsense.
What industry is SonALAsense in?
SonALAsense's product category is Clinical-Stage Oncology Therapeutics (Drug-Device Combination). Its primary akta.pro industry code is HLAIAIAN, Rare Pediatric & Congenital Disorder Therapies. Its NAICS code is 541714 and its SIC code is 2836.